SBE-β-CD CAS 182410-00-0 Betadex Sulfobutyl Etere Sodium Assay 95.0~105.0%

Betadex Sulfobutyl Ether Sodium
C42H70−nO35 · (C4H8SO3Na)n 2163 pamene n = 6.5
Beta cyclodextrin sulfobutyl ethers, sodium salt;
Beta cyclodextrin sulfobutyl ether sodium [182410-00-0].
TANTHAUZO
Betadex Sulfobutyl Etere Sodium imakonzedwa ndi alkylation ya betadex pogwiritsa ntchito 1,4-butane sultone pansi pazifukwa zofunika.
Avereji ya kulowetsedwa mu betadex ndi NLT 6.2 ndi NMT 6.9.
Lili ndi NLT 95.0% ndi NMT 105.0% ya C42H70−nO35 · (C4H8SO3Na)n (n = 6.2–6.9), yowerengedwa pa maziko a anhydrous.
CHIZINDIKIRO
• A. KUYAMBIRA KWA INFRARED <197K>
• B. Nthawi yosungira pachimake chachikulu cha Sample solution ikufanana ndi yankho lokhazikika, monga momwe zapezedwa mu Assay.
• C. Imakwaniritsa zofunikira za mayeso a Average Degree of Substitution.
• D. KUYESA KUDZIWA KWAMBIRI, Sodium 〈191〉
ZOYESA
• NTCHITO
Gawo la mafoni: 0.1 M potaziyamu nitrate mu osakaniza acetonitrile ndi madzi (1:4)
Njira yothetsera: 10 mg/mL ya USP Betadex Sulfobutyl Etere Sodium RS mu gawo la Mobile
Yankho lachitsanzo: 10 mg/mL ya Betadex Sulfobutyl Ether Sodium mu gawo la Mobile
Chromatographic system
(Onani Chromatography <621>, Kukwanira Kwadongosolo.)
Njira: LC
Detector: Refractive index
Kutentha kwa detector: 35 ± 2 °
Mzere: 7.8-mm × 30-cm yowunikira;kunyamula L37.[Dziwani-Tsukani mzatiwo ndi yankho la acetonitrile ndi madzi (1:9) mukamaliza mndandanda.]
Kuthamanga: 1.0 mL / min
Kukula kwa jekeseni: 20µL
Kuyenerera kwadongosolo .
Chitsanzo: Njira yothetsera
Zofunikira zoyenera
Kupatuka kofananira: NMT 2.0%
Kusanthula
Zitsanzo: Yankho lokhazikika ndi yankho lachitsanzo
Werengani kuchuluka kwa betadex sulfobutyl ether sodium [C42H70−nO35 · (C4H8SO3Na)n] mu gawo la Betadex Sulfobutyl Ether Sodium yotengedwa:
Zotsatira = (rU/rS) × (CS/CU) × 100
rU = yankho lapamwamba la betadex sulfobutyl ether
sodium kuchokera ku Sample solution
rS = yankho lapamwamba la betadex sulfobutyl ether
sodium kuchokera ku Standard solution
CS = kuchuluka kwa USP Betadex Sulfobutyl Ether
Sodium RS mu Standard solution (mg/mL)
CU = kuchuluka kwa Betadex Sulfobutyl Etere Sodium mu Sample solution (mg/mL)
Njira zolandirira: 95.0% ~ 105.0% pamaziko a anhydrous
ZOCHITSA
• ZINTHU ZONSE, Njira II <231>: NMT 5 ppm
• LIMIT OF BETA CYCLODEXTRIN (BETADEX)
Yankho A: 25 mm sodium hydroxide
Yankho B: 250 mM sodium hydroxide ndi 1 M potaziyamu nitrate
Gawo la mafoni: Onani Table 1.
Table 1

Yankho lokhazikika: 2 µg/mL ya USP Beta Cyclodextrin RS
Yankho lachitsanzo: 2 mg/mL ya Betadex Sulfobutyl Etha Sodium
Chromatographic system
(Onani Chromatography <621>, Kuyenerera Kwadongosolo ndi Ion Chromatography <1065>.)
Njira: IC
Chodziwira: Pulsed amperometry (selo ya amperometric yokhala ndi ma elekitirodi ogwiritsira ntchito golide ndi ma elekitirodi a siliva)
Mzere
Mlonda: 4.0-mm × 5-cm anion-kusinthanitsa;kunyamula L61
Kusanthula: 4.0-mm × 25-cm anion-exchange;
kunyamula L61
Kutentha kwapakati: 50 ± 2 °
Kuthamanga: 1.0 mL / min
Kukula kwa jekeseni: 20µL
Waveform for pulsed amperometric detector: Onani Gulu 2.
Table 2

Kuyenerera kwadongosolo
Chitsanzo: Njira yothetsera
Zofunikira zoyenera
Kupatuka kofananira: NMT 5.0%
Kusanthula
Zitsanzo: Yankho lokhazikika ndi yankho lachitsanzo
Werengani kuchuluka kwa beta cyclodextrin (betadex) mu gawo la Betadex Sulfobutyl Ether Sodium yotengedwa:
Zotsatira = (rU/rS) × (CS/CU) × F × 100
rU = kuyankha kwapamwamba kwa beta cyclodextrin kuchokera ku Sample solution
rS = kuyankha kwapamwamba kwa beta cyclodextrin kuchokera ku Standard solution
CS = kuchuluka kwa USP Beta Cyclodextrin RS mu Standard solution (µg/mL)
CU = kuchuluka kwa Betadex Sulfobutyl Etere Sodium mu Sample solution (mg/mL)
F = chinthu chotembenuka (10-3 mg/µg)
Zoyenera kulandira: NMT 0.1%
• MALIRE A 1,4-BUTANE SULTONE
Njira yothetsera mkati: 0.25 µg/mL ya diethyl sulfone
Njira yothetsera A: 0.5 µg/mL ya 1,4-butane sultone
Njira yokhazikika ya katundu B: 1.0 µg/mL ya 1,4-butane sultone
Njira yothetsera katundu C: 2.0 µg/mL ya 1,4-butane sultone
Sample stock solution: 250 mg/mL ya Betadex Sulfobutyl Etere Sodium mu Internal standard solution
Yankho lopanda kanthu, ndi zitsanzo za mayankho A, B, C, ndi D:
Tsatirani Table 3 kuti muyike kuchuluka kwa yankho la Internal standard, njira iliyonse ya Standard stock solution, Sample stock solution, madzi, kapena methylene chloride mu chubu chilichonse choyezera galasi chokhala ndi choyimitsa.[Dziwani-A screw-capped, 10-mL test chubu ndi yoyenera.] Sakanizani pa vortex mixer pa chubu iliyonse yoyesera kwa 30 s, ndipo mulole kuti ayime kwa osachepera 5 min kapena mpaka kulekanitsa kwathunthu kwa gawolo.Chotsani gawo la organic mu GC vial ndikusindikiza.[DZIWANI-Mosamala kwambiri tengani gawo locheperapo lotheka la gawo lamadzi.] Zowonjezera zowonjezera za 1,4-butane sultone mu Zitsanzo zothetsera A, B, C, ndi D ndi 0.5, 1.0, 2.0, ndi 0 µg, motsatira.
Table 3

[DZIWANI-Konzekerani mwamsanga musanagwiritse ntchito.]
Chromatographic system
(Onani Chromatography <621>, Kukwanira Kwadongosolo.)
Njira: GC
Chodziwira: Moto ionization
Mzere: 0.32-mm × 25-m fused-silica capillary column;0.5-µm wosanjikiza wa gawo G46
Kutentha
Chowunikira: 270 °
Khomo la jekeseni: 200 °
Mzere: Onani pulogalamu ya kutentha mu Tebulo 4
Table 4
Kutentha Koyamba (°) Kutentha Kwambiri (°/min) Kutentha Komaliza (°) Kusunga Nthawi Pakutentha Komaliza (min)
100 10 200 -
200 35 270 5
Gasi wonyamula: Helium, nthawi zambiri pa 12 psi inlet inlet
Kukula kwa jekeseni: 1.0 µL
Mtundu wa jakisoni: jakisoni wopanda splitless kwa mphindi 0,5, kenako kugawanika pa 50 mL/mphindi.[DZIWANI-Kugwiritsa ntchito jekeseni yoyenera yopanda jekeseni ndikulimbikitsidwa.]
Kuyenerera kwadongosolo
Chitsanzo: Chitsanzo cha yankho B
[DZIWANI-Nthawi zosungirako za diethyl sulfone ndi 1,4-butane sultone ndi 0.7 ndi 1.0, motsatana.]
Zofunikira zoyenera
Kupatuka kofananira: NMT 10.0%
Kusanthula
Zitsanzo: Yankho lopanda kanthu, zitsanzo za mayankho A, B, C, ndi D
Konzani chiŵerengero cha mayankho apamwamba a 1,4-butane sultone ku diethyl sulfone mu Sample solution A, B, C, kapena D pochotsa chiŵerengero cha mayankho apamwamba a 1,4-butane sultone ku ethyl sulfone mu njira yopanda kanthu. .Konzani chiŵerengero chowongolera cha nsonga yapamwamba ya 1,4-butane sultone kuyankha pachimake cha diethyl sulfone mu Chitsanzo cha yankho A, B, C kapena D, motsutsana ndi kuchuluka kwake, mu µg, kwa 1,4-butane sultone.Onjezani mzere wolumikiza mfundo pa graph mpaka utakumana ndi axis ya kuchuluka.Mtunda wapakati pa mfundoyi ndi mphambano ya nkhwangwa ukuyimira kuchuluka kwa 1,4-butane sultone, A, mu µg, mu gawo la 4-mL la Sample stock solution.Werengani zomwe zili mu 1,4-butane sultone mu gawo la Betadex Sulfobutyl Ether Sodium yotengedwa:
Zotsatira = A/(VExt × CU × F)
A = zotsimikizika pamwambapa
VExt = voliyumu ya Sample stock solution yomwe imagwiritsidwa ntchito pochotsa, 4.0 mL
CU = kuchuluka kwa Betadex Sulfobutyl Etere Sodium mu Sample stock solution (mg/mL)
F = chinthu chotembenuka (10-3 g/mg)
Njira zolandirira: hydroxybutane-1-sulfonic acid, kapena NMT 0.5 ppm
• MALIRE WA SODIUM CHLORIDE, 4-HYDROXYBUTANE-1-SULFONIC ACID, NDI BIS(4-SULFOBUTYL) ETI DISODIUM
Yankho A: 5 mM sodium hydroxide, degas mu chotengera chotsekedwa kwa 15 min
Yankho B: 25 mM sodium hydroxide, degas mu chotengera chotsekedwa kwa 15 min
Gawo la mafoni: Onani Table 5
Table 5

Njira yotsuka ndizambiri A: 50 mm sodium citrate
Njira yotsuka ndizambiri B: 150 mm sodium hydroxide
Yankho lokhazikika: Konzani yankho lokhala ndi milingo yodziwika ya 8 µg/mL ya USP Sodium Chloride RS, 4µg/mL ya 4-hydroxybutane-1-sulfonic acid, ndi 4 µg/mL ya bis(4-sulfobutyl) ether disodium.
Yankho lachitsanzo: 4 mg/mL ya Betadex Sulfobutyl Etha Sodium
Chromatographic system
(Onani Chromatography <621>, Kuyenerera Kwadongosolo ndi Ion Chromatography <1065>.)
Njira: IC
Chodziwira: Kuwongolera
Kutalika: 30 µS
Pakali pano: 100 mA
Mzere: [Dziwani-Pamapeto paulendo uliwonse, yeretsani ndime pogwiritsa ntchito Column wash solution A pamadzi otaya 1 mL/min kwa 35 min kenako pogwiritsa ntchito Column wash solution B pamlingo womwewo wa 35 min.]
Mlonda: 4.0-mm × 5.0-cm anion-kusinthanitsa;kunyamula L61
Kusanthula: 4.0-mm × 25-cm anion-exchange;kunyamula L61
Kutentha kwapakati: 30 °
Wopondereza: Micromembrane anion autosuppressor1 kapena njira yoyenera yopondereza mankhwala
Kupondereza: Kudziletsa
Kuthamanga: 1.0 mL / min
Kukula kwa jekeseni: 20µL
Kuyenerera kwadongosolo
Chitsanzo: Njira yothetsera
[ZOYENERA-NKHANI zosungira zimaperekedwa kuti mudziwe zambiri zokha.Nthawi zotsalira za 4-hydroxybutane-1-sulfonate ion, chloride ion, ndi bis(sulfobutyl) ether ion ndi 1.0, 1.4, ndi 8.6, motsatana.]
Zofunikira zoyenera
Kusamvana: NLT 2.0
Kupatuka kofananira: NMT 10.0%
Kusanthula
Zitsanzo: Yankho lokhazikika ndi yankho lachitsanzo
Kuwerengera kuchuluka kwa sodium chloride, 4-hydroxybutane-1-sulfonic acid, kapena bis(sulfobutyl) etha disodium mu gawo la Betadex Sulfobutyl Etha Sodium yotengedwa:
Zotsatira = (rU/rS) × (CS/CU) × F × 100
rU = yankho lapamwamba la sodium chloride, 4-hydroxybutane-1-sulfonic acid, kapena bis(sulfobutyl) ether disodium kuchokera ku Sample solution
rS = yankho lapamwamba la sodium chloride, 4-hydroxybutane-1-sulfonic acid, kapena bis(sulfobutyl) ether disodium kuchokera ku Standard solution
CS = kuchuluka kwa sodium chloride, 4-hydroxybutane-1-sulfonic acid, kapena bis(sulfobutyl) ether disodium mu Standard solution (µg/mL)
CU = kuchuluka kwa Betadex Sulfobutyl Etere Sodium mu Sample solution (mg/mL)
F = chinthu chotembenuka (10−3 0 100 0 mg/µg)
Zovomerezeka zovomerezeka
Sodium chloride: NMT 0.2%
4-Hydroxybutane-1-sulfonic acid: NMT 0.09%
Bis(sulfobutyl) ether disodium: NMT 0.05%
MAYESO AKE
KUYESA KWA BACTERIAL ENDOTOXINS <85>: Mlingo wa mabakiteriya endotoxins ndi kotero kuti zofunikira pansi pa mlingo woyenera mawonekedwe a monograph (s) omwe Betadex Sulfobutyl Ether Sodium amagwiritsidwa ntchito akhoza kukumana.Kumene chizindikirocho chimanena kuti Betadex Sulfobutyl Etere Sodium iyenera kuchitidwa mowonjezereka panthawi yokonzekera mawonekedwe a jekeseni, mlingo wa endotoxins wa bakiteriya ndi wofunika pansi pa mawonekedwe oyenerera a monograph (s) omwe Betadex Sulfobutyl Ether Sodium amagwiritsidwa ntchito. akhoza kukumana.
• KUYESA KWA MICROBIAL ENUMERATION <61> ndi KUYESA KWA MICROORGANISMS WODZIWA <62>: Chiwerengero chonse cha ma microbial aerobic sichidutsa 100 cfu/g, ndipo kuchuluka kwa nkhungu ndi yisiti sikudutsa 50 cfu/g.Imakwaniritsa zofunikira pakuyesa kwa Escherichia coli.
• KUWONEKA KWA VUNDULULU
Yankho lachitsanzo: 30% (w/v) yankho
Kusanthula: Yang'anani yankho lachitsanzo pogwiritsa ntchito bokosi lopepuka motsutsana ndi zoyera ndi zakuda, ndikujambulitsa kukhalapo kwa chifunga chilichonse, fulorosenti, ulusi, timadontho, kapena zinthu zakunja.
Njira zovomerezera: Yankho lake ndi lomveka bwino, ndipo kwenikweni alibe tinthu tating'ono ta zinthu zakunja.
• AVERAGE DIGRERE YA KUSINTHA M'MALO
Thamangani ma electrolyte: 30 mM benzoic acid ndikusinthidwa kukhala pH yomwe ili yoyenera chida chogwiritsidwa ntchito powonjezera 100 mM tris(hydroxymethyl) aminomethane buffer.
[ZOYENERA-Chifukwa cha kusiyana pakati pa ma capillary, pH imodzi ya electrolyte yogwiritsidwa ntchito padziko lonse sinatchulidwe.
M'malo mwake, pH yoyenera yokhudzana ndi capillary iliyonse iyenera kutsimikiziridwa molingana ndi buku lothandizira.]
Njira yothetsera: 10 mg/mL ya USP Betadex Sulfobutyl Etere Sodium RS
Yankho lachitsanzo: 10 mg/mL ya Betadex Sulfobutyl Etha Sodium
Kapilari rinsing Njira: Gwiritsani ntchito mbale zosiyana za electrolyte zotsukira capillary ndi kusanthula zitsanzo.Chitani zodzitchinjiriza zisanachitike tsiku lililonse musanawunikenso: yambani capillary ndi 0.1 N sodium hydroxide kwa mphindi 30, ndi madzi a NLT 2 h, ndi Run electrolyte kwa NLT 1 h.Chitani ma rinses asanabadwe musanayambe jekeseni iliyonse motere.Tsukani capillary ndi 0.1 N sodium hydroxide kwa NLT 1 min, ndi Thamangani electrolyte kwa NLT 3 min.Ngati capillary yatsopano ikugwiritsidwa ntchito, kuwonjezera pa zotsukira zokhazikika zomwe zafotokozedwa pamwambapa, capillary yatsopano imafuna kutsuka musanagwiritse ntchito koyamba.Tsukani capillary yatsopano ndi 1 M sodium hydroxide kwa 1 h, kenako ndikutsuka madzi kwa maola awiri.
Electrophoretic system
(Onani Capillary Electrophoresis <1053>.)
Njira: CE yogwira ntchito kwambiri
Chowunikira: Inverse UV 200 nm, yokhala ndi bandwidth ya 20nm.[Dziwani-Kuzindikira kutalika kwa 205 nm yokhala ndi bandwidth ya 10 nm kungagwiritsidwe ntchito ngati njira ina.]
Mzere: Sodium Peaks I–X (% Peak Area) 50-µm × 50-cm silika wosakanikirana
Kutentha kwapakati: 25 °
Magetsi ogwiritsidwa ntchito: 0.00 mpaka +30.00 kV mzere wozungulira wopitilira mphindi 10, kenako pa 30 kV kwa mphindi 20 zina
Kukula kwa jakisoni: Ma voliyumu ofanana pa 0.5 psi kwa 10 s
Kuyenerera kwadongosolo
Chitsanzo: Njira yothetsera
[ZOYENERA-Onani Table 6 za pafupifupi nthawi zosamuka kwa betadex sulfobutyl ether sodium peaks I–X (betadex sulfobutyl ether sodium peaks I, II, III, ..., X, ili ndi molekyulu ya beta cyclodextrin yokhala ndi 1, 2, 3, ..., 10 sulfobutyl substituent(s), motsatana).Nthawi zakusamuka kwachibale ndizongodziwa zambiri zongothandizira kuzindikira pachimake.]
Ndime 6

Zofunikira zoyenera
Kusamvana: NLT 0.9, pakati pa betadex sulfobuty ether sodium peak IX ndi betadex sulfobutyl ether sodium pachimake X
Kusanthula
Zitsanzo: Thamangani ma electrolyte, madzi, yankho lokhazikika, ndi yankho lachitsanzo
Jayini yankho lokhazikika ndi njira ya Zitsanzo pogwiritsira ntchito mphamvu yosiyana ya 0.5 psi, yofanana ndi 34 mbar, kwa 10 s, kutsatiridwa ndi jekeseni wa Run electrolyte pa 0.5 psi kwa 2 s.[Dziwani-Majakisoni othamanga ayenera kupangidwa ndi vial yamadzi kapena Run electrolyte kumapeto kwa capillary.]
Lembani ma electropherogram, ndi kuyeza mayankho apamwamba a betadex sulfobutyl ether peaks sodium (I mpaka X).Werengerani nsonga yokonzedwa, AI, pachimake chilichonse mu eletropherogram:
Malo Apamwamba Okonzedwa A = Malo Apamwamba x Utali Wamphamvu wa Capillary (cm) / Nthawi Yosamuka
Konzani madera omwe ali pachimake powawonetsa lililonse ngati gawo la gawo lonse la maenvulopu okonzedwa bwino:
Malo Okhazikika, NA: A / n∑i=1 Ai x 100
n = mlingo wapamwamba kwambiri wolowa m'malo
Tsimikizirani kuchuluka kwapakati pakusintha:
Avereji ya Digiri ya M'malo = n∑i=1 (Mlingo wa Kusintha Pachimake x NA) / 100
Njira zolandirira: 6.2 ~ 6.9 pamlingo wapakati wolowa m'malo
Pamtundu uliwonse wa betadex sulfobutyl ether sodium peaks I–X, onani malire (% malo okwera kwambiri) mu Gulu 7.
Ndime 7

• PH <791>: 4.0-6.8, mu 30% (w/v) yankho m'madzi opanda carbon dioxide
• KUSINTHA KWA MADZI, Njira I <921>: NMT 10.0%
ZOWONJEZERA ZOFUNIKA
• KUPAKA NDI KUKUSIKA: Sungani m’zotengera zotsekedwa bwino, ndipo sungani pamalo otentha.Tetezani ku chinyezi.
• KUIKHA LEBO: Ilembeni posonyeza kuti ikugwiritsidwa ntchito popanga jekeseni wa jekeseni.
• MFUNDO ZA USP REFERENCE <11>
USP Beta Cyclodextrin RS
USP Betadex Sulfobutyl Etere Sodium RS
USP Endotoxin RS
USP Sodium Chloride RS■1S (NF30)